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FDA Drug Application 018101 by ENDO PHARMS

Application Number018101
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/3/1980N       
AP04/19/1993SE2       
AP01/23/1998SCM       
AP08/20/1998SCS       
AP03/12/1999SCM       
AP012/6/2000SLR       
AP011/18/2003SLR6946009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18101slr009,16023slr037ltr.pdf 11/25/2003
AP011/18/2003SLR8402009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf 4/27/2004
AP011/18/2003SLR14069009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016023s037_018101s009_SymmetrelTOC.cfm 5/8/2006
AP03/2/2007SLR15974014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016023s039, 018101s014.pdf 3/7/2007
AP03/2/2007SLR15987014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf 3/7/2007
AP09/24/2008SLR20889015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016023s040, 018101s015ltr.pdf 9/26/2008
AP09/24/2008SLR20937015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.pdf 10/3/2008
AP02/2/2009SLR21702016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016023s041,018101s016ltr.pdf 2/3/2009
AP02/2/2009SLR21747016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.pdf 2/4/2009




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